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STEGLUJAN

ERTUGLIFLOZIN AND SITAGLIPTIN

Manufacturer: Merck Sharp & Dohme LLC

Score: 141.0

Quick Summary

STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food, and can be increased to 15 mg ertugliflozin/100 mg sitagliptin once daily for additional glycemic control. STEGLUJAN is not recommended for patients with severe renal impairment, end-stage renal disease, or on dialysis, and its use is contraindicated in these populations. Important safety information includes the risk of diabetic ketoacidosis, pancreatitis, lower limb amputation, acute renal failure, volume depletion, urosepsis and pyelonephritis, heart failure, hypoglycemia, necrotizing fasciitis of the perineum, genital mycotic infections, hypersensitivity reactions, severe and disabling arthralgia, and bullous pemphigoid.

Key Clinical Findings and Indications

  • STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus
  • Has not been studied in patients with a history of pancreatitis

Important Safety Information

Warning

STEGLUJAN may cause diabetic ketoacidosis, pancreatitis, lower limb amputation, acute renal failure, volume depletion, urosepsis and pyelonephritis, heart failure, hypoglycemia, necrotizing fasciitis of the perineum, genital mycotic infections, hypersensitivity reactions, severe and disabling arthralgia, and bullous pemphigoid

Contraindications

  • Severe renal impairment (eGFR less than 30 mL/min/1.73 m^2)
  • End-stage renal disease (ESRD) or on dialysis
  • Hypersensitivity to sitagliptin, ertugliflozin, or any excipient in STEGLUJAN

Adverse Reactions

  • Female genital mycotic infections
  • Male genital mycotic infections
  • Urinary tract infections
  • Headache
  • Vaginal pruritus
  • Increased urination
  • Nasopharyngitis
  • Back pain
  • Weight decreased
  • Thirst

Dosing Recommendations

General Guidance

Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily for additional glycemic control

Type 2 diabetes mellitus

Adult Dose

5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Based on animal data showing adverse renal effects, STEGLUJAN is not recommended during the second and third trimesters of pregnancy

Nursing Mothers

  • No data available

Pediatric Use

  • Safety and effectiveness of STEGLUJAN in pediatric patients under 18 years of age have not been established

Geriatric Use

  • No dosage adjustment of STEGLUJAN is recommended based on age
  • Elderly patients are more likely to have decreased renal function

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